Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot be Removed by Surgery (NCT02072356) | Clinical Trial Compass
CompletedEarly Phase 1
Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot be Removed by Surgery
United States290 participantsStarted 2010-10-11
Plain-language summary
This clinical trial studies radiolabeled glass beads (yttrium Y 90 glass microspheres) in treating patients with unresectable hepatocellular carcinoma. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be an effective treatment for liver cancer.
Who can participate
Age range8 Years
SexALL
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Inclusion Criteria:
* Diagnosis of intrahepatic malignancy including but not limited to HCC; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha-fetoprotein (AFP) and clinical findings
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
* Life expectancy \>= 3 months
* \> 4 weeks since prior radiation, surgery or chemotherapy
* Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
* Ineligible for surgical resection
Exclusion Criteria:
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times upper limit of normal (UNL)
* Serum bilirubin \> 2.0 mg/dl (unless segmental infusion is planned)
* Any contraindications to angiography and hepatic artery catheterization such as:
* History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated
* Bleeding diathesis, not correctable by usual forms of therapy
* Severe peripheral vascular disease that would preclude catheterization
* Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
* Evidence of pulmonary insufficiency
* Evidence of any detectable technetium-99m macroaggregated serum albumin (Tc-99m MAA) flow to the stomach…
What they're measuring
1
Response to treatment
Timeframe: Up to 2 years
2
Survival time
Timeframe: Up to 2 years
3
Adverse experiences
Timeframe: Up to 2 years
Trial details
NCT IDNCT02072356
SponsorOhio State University Comprehensive Cancer Center